FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
65862-010
Requested package NDC
65862-010-15
11-digit product format
658620010
Labeler code
65862
Product ID
65862-010_1c59d7bc-6118-4707-80c0-886ac00bab09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077095
Marketing category
ANDA
Marketing start
2005-01-14
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-01065862-010-15UNFINISHEDActive or certified unfinished drug listing2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077095-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14
A077095-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14
A077095-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077095-001AB
A077095-002AB
A077095-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077095-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077095-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077095-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077095-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077095-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077095-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077095-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077095-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077095-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077095-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077095-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077095-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077095-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077095-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077095-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077095-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077095-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077095-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077095-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077095-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861004Internal RxNorm lookup
861007Internal RxNorm lookup
861010Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ac6d01a-af26-44e7-ae2e-3618de0080aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-010-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10016
65862-010-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016
65862-010-33Metformin Hydrochloride300 in 1 BOTTLETABLET, FILM COATED30016
65862-010-46Metformin Hydrochloride2000 in 1 BOTTLETABLET, FILM COATED200016
65862-010-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5016
65862-010-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6016
65862-010-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016
65862-010-99Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-010-01EA - Each65862-010cf153373-d77b-45e8-b5b0-9c1ad2428d7212012-07-24
65862-010-05EA - Each65862-010c5f1fe48-2a3d-4ea3-a9ed-bbd558974f7c12012-07-24
65862-010-22EA - Each65862-010d167044d-81f1-4a16-a991-9de0e2f826a612024-06-10
65862-010-46EA - Each65862-0107147d821-6c0f-4101-bc02-27fab470ec4c12012-07-24
65862-010-90EA - Each65862-01051425598-1fa4-4421-bad2-a8d0b34622cb12012-07-24
65862-010-99EA - Each65862-0100e50e7e5-743d-4c59-b494-275e9fc5cc6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-010METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 8 package rows20240104_4ac6d01a-af26-44e7-ae2e-3618de0080aa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (product): 65862-010
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions23aa50c5-28fe-4322-b5c6-1f1c48409b162025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390c3bdf-bfaf-203e-e063-6394a90a7d202025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metFORMIN HCl 500 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metFORMIN HCl 850 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metformin hydrochloride 500 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metformin hydrochloride 850 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin HCl 1 GM Oral TabletSY23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metFORMIN HCl 1000 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metFORMIN HCl 500 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metFORMIN HCl 850 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin hydrochloride 1000 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metformin hydrochloride 500 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metformin hydrochloride 850 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin HCl 1 GM Oral TabletSY4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metFORMIN HCl 500 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metFORMIN HCl 850 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metformin hydrochloride 500 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metformin hydrochloride 850 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin HCl 1 GM Oral TabletSY23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metFORMIN HCl 1000 MG Oral TabletPSN5d8d654a-9bb4-4c87-ab43-c21c4e87470810
861004metformin hydrochloride 1000 MG Oral TabletSCD5d8d654a-9bb4-4c87-ab43-c21c4e87470810
861004metformin HCl 1 GM Oral TabletSY5d8d654a-9bb4-4c87-ab43-c21c4e87470810
861004metFORMIN HCl 1000 MG Oral TabletPSN1d7556eb-82b4-4085-b0b1-dc061b216feb6
861004metformin hydrochloride 1000 MG Oral TabletSCD1d7556eb-82b4-4085-b0b1-dc061b216feb6
861004metformin HCl 1 GM Oral TabletSY1d7556eb-82b4-4085-b0b1-dc061b216feb6
861004metFORMIN HCl 1000 MG Oral TabletPSN415c945b-6c6e-2a55-e054-00144ff8d46c4
861004metFORMIN HCl 1000 MG Oral TabletPSN1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metFORMIN HCl 1000 MG Oral TabletPSNdb113f46-6fac-9005-e053-2995a90a017a4
861007metFORMIN HCl 500 MG Oral TabletPSN1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metformin hydrochloride 1000 MG Oral TabletSCD415c945b-6c6e-2a55-e054-00144ff8d46c4
861004metformin hydrochloride 1000 MG Oral TabletSCDdb113f46-6fac-9005-e053-2995a90a017a4
861004metformin hydrochloride 1000 MG Oral TabletSCD1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861007metformin hydrochloride 500 MG Oral TabletSCD1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metformin HCl 1 GM Oral TabletSYdb113f46-6fac-9005-e053-2995a90a017a4
861004metformin HCl 1 GM Oral TabletSY415c945b-6c6e-2a55-e054-00144ff8d46c4
861004metformin HCl 1 GM Oral TabletSY1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metFORMIN HCl 1000 MG Oral TabletPSNafb183f6-a13c-4f00-82d5-9fe336173d343
861004metformin hydrochloride 1000 MG Oral TabletSCDafb183f6-a13c-4f00-82d5-9fe336173d343
861004metformin HCl 1 GM Oral TabletSYafb183f6-a13c-4f00-82d5-9fe336173d343
861004metFORMIN HCl 1000 MG Oral TabletPSN57066c55-7841-4b0b-a2a6-15c14e6e59552
861004metformin hydrochloride 1000 MG Oral TabletSCD57066c55-7841-4b0b-a2a6-15c14e6e59552
861004metformin HCl 1 GM Oral TabletSY57066c55-7841-4b0b-a2a6-15c14e6e59552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-010-15658620010151500 TABLET, FILM COATED in 1 BAG (65862-010-15)14-JAN-05Current